NCT00491855

Oxaliplatin and Paclitaxel Plus Bevacizumab in Advanced Peritoneal Carcinomatosis

Phase I Trial of Intraperitoneal Oxaliplatin and Paclitaxel Plus Intravenous Paclitaxel and Bevacizumab in the Treatment of Advanced Peritoneal Carcinomatosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research is to learn acceptable dosages of paclitaxel, oxaliplatin, and Avastin (bevacizumab) that can be given in combination to patients with advanced peritoneal carcinomatosis. The safety of this drug combination will also be studied.

Detailed description

The Study Drugs: Paclitaxel is designed to block cancer cells from dividing, which may cause them to die. Oxaliplatin is designed to keep new cancer cells from growing Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels. Study Drug Dose Levels: Up to 12 study drug dose levels will be tested in this study. Participants will be enrolled in groups of 3. The first 3 participants will be enrolled at the lowest dose level. If there are no intolerable side effect seen, the next 3 participants will be enrolled into the next higher dose level. This will continue until acceptable dose levels of the study drugs are found. The dose level that you are assigned to will depend on when you enroll on this study. You will receive the same dose level for the entire study unless you develop side effects, in which case doses of the drugs will be decreased by your doctor. Drug Administration: If you agree to participate in this study, you will have a catheter placed in your abdomen before receiving study drug. A catheter is a sterile flexible tube that will be placed while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form. On Day 1, you will receive bevacizumab followed by paclitaxel through a needle in your vein over 24 hours. On Day 2, after you have completed the paclitaxel infusion, you will be given about 1 quart of fluid containing oxaliplatin into the abdomen through the catheter over 15 minutes. On Day 8, you will be given about 1 quart of fluid containing paclitaxel into the abdomen through the catheter over 15 minutes. Every 21 days is called a study "cycle." Study Visits: During each cycle, you will see your doctor in his office to make sure that you are still eligible to receive study drugs. * Blood (about 1 tablespoon) will be drawn for routine tests each day during hospitalization and then once a week as an outpatient. * A urine sample will be collected once each cycle for routine tests. * You will have scans such as a chest x-ray, CT, MRI, Positron emission tomography (PET), and/or PET/CT scan after every 2 cycles (6 weeks) or earlier if the study doctor thinks it is in your best interest, or the cancer gets worse. These scans are to check the status of the disease. If the study doctor thinks it is more appropriate for you, other types of scans may need to be performed. The study doctor will discuss these scans with you, and you may be asked to sign a separate consent form. Length of Study: You will be taken off study if the disease gets worse or intolerable side effects occur. End-of-Study Visit: If you are taken off study, you will be asked to have an end-of-study visit. At this visit, the following tests will be performed: * Blood (about 1 tablespoon) and urine will be collected for routine tests. * You will have repeat scans such as a chest x-ray, CT, MRI, PET, and/or PET/CT scan to check the status of the disease. If the study doctor thinks it is more appropriate for you, other types of scans may need to be performed. The study doctor will discuss these scans with you, and you may be asked to sign a separate consent form. This is an investigational study. Paclitaxel, oxaliplatin, and bevacizumab are FDA-approved drugs, but their use in this study is investigational. Up to 72 patients will take part in this study. All will be enrolled at MD Anderson.

Conditions

• Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab	Starting dose level 2.5 mg/kg given intravenously on day 1.
DRUG	Oxaliplatin	Starting dose level 25 mg/m\^2 given intraperitoneally on day 2.
DRUG	Paclitaxel	Starting dose level 110 mg/m\^2 given continuous infusion on day 1 and 30 mg/m\^2 given intraperitoneally on day 8.

Timeline

• Start date: 2007-06-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2007-06-26
• Last updated: 2013-01-03

Locations

1 site across 1 country: United States